Vascular Prosthetic Delivery Device And Method Of Use

• US 20130274856A1
• Filed: 03/14/2013
• Published: 10/17/2013
• Est. Priority Date: 04/12/2012
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Christian, Fletcher, Canning, John C.
• Granted Patent: US 8,998,970 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery device includes a guidewire catheter and a delivery assembly extending about the guidewire catheter. The delivery assembly includes a locking mechanism that selectively engages a proximal handle of the delivery assembly with a push rod to which a vascular prosthesis is directly or indirectly attached. When an actuator selectively disengages the proximal handle from the handle body, rotation of the proximal handle is independent of longitudinal movement of the vascular prosthesis relative to the handle body, whereby the proximal handle can be moved along the handle body with rotation.

Claims

1. A delivery device, comprising:

a) a guidewire catheter having a proximal end and a distal end; and

b) a delivery assembly extending about the guidewire catheter, including;

i) a handle body, having a major longitudinal axis, a proximal end and a distal end,

ii) a delivery catheter having a distal end extending from within the distal end of the handle body and about the guidewire catheter,

iii) a push rod extending about the guidewire catheter and within the delivery catheter, the push rod being fixed to the guidewire catheter at the proximal end of the guidewire catheter proximal to the handle body,

iv) a proximal handle extending about the handle body and axially fixed to the delivery catheter, the proximal handle being selectively fixed to the push rod, wherein the proximal handle is rotatable about the handle body and rotation of the proximal handle about the handle body translates to longitudinal movement of the delivery catheter and, selectively, of the push rod relative to the handle body, and

v) a locking mechanism at the handle body that selectively engages the proximal handle with the push rod.

2. The delivery device of claim 1, further including an actuator at the proximal handle that selectively disengages the proximal handle from the handle body, whereby rotation of the proximal handle is independent of longitudinal movement of the delivery catheter relative to the handle body.

3. The delivery device of claim 2, wherein the proximal handle includes an end that defines teeth that move transversely to a major longitudinal axis of the handle body when the proximal handle is rotated about the handle body, and further including,

a) a gear rack extending along the major longitudinal axis of the handle body;

b) a linking gear engaging the teeth of the proximal handle end, the linking gear being rotatable about an axis transverse to the axis of rotation of the proximal handle; and

c) a pinion gear that engages the gear rack and the linking gear, whereby rotation of the proximal handle about the handle body translates to the longitudinal movement of the delivery catheter and, selectively, of the push rod relative to the handle body, whereby the actuator selectively disengages the linking gear from the pinion gear, thereby selectively disengaging rotation of the proximal handle from longitudinal movement of the proximal handle along the handle body.

4. The delivery device of claim 3, wherein the actuator includes,

a) an actuator housing that extends about the handle body and is rotatably linked to the proximal handle, whereby the actuator housing is movable along the handle body without rotating about the handle body while the proximal handle rotates about the handle body;

b) a push-button at the actuator housing;

c) a pinion gear extension that defines a coaxial opening that is coaxial with the pinion gear and defines at least one lateral opening that extends laterally from the coaxial opening;

d) a ball-bearing that sits at least partially within the lateral opening and locks the relative rotation of the linking gear and the pinion gear when displaced to extend radially beyond the pinion gear extension; and

e) a frustoconical center-pin that is biased radially outward from the major longitudinal axis of the handle body and abuts the push-button, whereby the frustoconical center-pin displaces the ball bearing radially outward through the lateral opening and locks the relative rotation of the linking gear and the pinion gear by the outward bias, thereby causing longitudinal movement of the proximal handle along the handle body when the proximal handle is rotated about the handle body and, when the push-button is depressed, selectively disengages the linking gear from the pinion gear, thereby selectively disengaging rotation of the proximal handle from longitudinal movement of the proximal handle along the handle body.

5. The delivery device of claim 4, wherein further including a distal grip at the distal end of the handle body, and wherein the locking mechanism includes:

a) a shifting knob at the distal grip that is rotatable about the handle body and defines teeth along the inside of the shifting knob that move transversely to the major longitudinal axis of the handle body when the shifting knob is rotated about the handle body, and wherein the locking mechanism has at least two fixed positions relative to the handle body;

b) a drive shaft having a proximal end and a distal end, wherein the distal end defines teeth that engage the teeth of the shifting knob, and extend along a major longitudinal axis of the drive shaft;

c) a drive gear along the drive shaft and that defines teeth that engage the teeth along the drive shaft, whereby the shifting knob is engaged with the drive gear at all positions of the shifting knob; and

d) a first locking component extending about the push rod, the locking component being linked to the proximal handle and the drive gear, whereby, in a first position of the shifting knob, the first locking component engages the proximal handle with the push rod, and rotation of the shifting knob from the first position to a second position causes rotation of the drive shaft which, in turn, causes rotation of the drive gear and disengagement of the first locking component from the push rod, thereby allowing independent movement of the delivery catheter along the longitudinal axis of the handle body relative to the push rod when the proximal handle is moved along the major longitudinal axis of the handle body.

6. The delivery device of claim 5, wherein the locking mechanism further includes a second locking component, the second locking component extending about the push rod, fixed to the handle body and linked to the shifting knob through the drive shaft, whereby rotation of the shifting knob from the first position to the second position causes engagement between the handle body and the push rod, thereby preventing longitudinal movement of the push rod relative to the handle body when the proximal handle is moved along the major longitudinal axis.

7. The delivery device of claim 6, further including an apex delivery device, including:

a) an apex clasp assembly having,

i) a distal capture component at a distal end of the guidewire catheter,

ii) a proximal capture component in mateable relation to the distal capture component, and

iii) an apex release catheter having a proximal end, the apex release catheter extending about the guidewire catheter and fixed to the proximal capture component; and

b) a proximal clasp assembly, having

i) a fixed component at the proximal end of the guidewire catheter, and

ii) an outer coupling at the proximal end of the apex release catheter and in mateable relation with the fixed component of the proximal clasp assembly, whereby movement of the outer coupling relative to the fixed component from a first position to a second position will cause relative movement of the proximal capture component relative to the distal capture component of the apex clasp assembly.

8. The delivery device of claim 7, wherein the shifting knob includes a third position, wherein the first locking component and the second locking component are disengaged from the push rod, whereby the push rod can be moved longitudinally relative to the handle body and the proximal handle by longitudinal movement of the push rod, thereby moving the guidewire catheter independently of the proximal handle and the handle body.

9. The delivery device of claim 8, wherein the push rod can be rotated radially.

10. The delivery device of claim 8, wherein the handle body defines a slot through which the actuator extends, and further including a plurality of constricting rings extending about the delivery catheter within the handle body, the constricting rings having an outside diameter greater than that of the slot, whereby the rings will prevent application of longitudinal compressive force by the proximal handle on the delivery catheter from causing the delivery catheter to buckle and thereby move through the slot and outside the handle body.

11. The delivery device of claim 10, wherein the constricting rings define an inside diameter that is smaller than the outside diameter of the delivery catheter, thereby forming an interference fit between them, and whereby the constricting rings can move longitudinally along the delivery catheter.

12. The delivery device of claim 10, further including an outer catheter fixed to and extending from the distal end of the handle body.

13. The delivery device of claim 12, wherein the outer catheter is rotatable relative to the handle body.

14. The delivery device of claim 13, further including a delivery sheath extending distally from the distal end of the delivery catheter.

15. The delivery device of claim 14, further including a vascular prosthesis radially constrained within the delivery sheath, and releasably fixed at a proximal end of the prosthesis to the apex delivery device.

16. The delivery device of claim 15, further including at least one stent at the proximal end of the prosthesis, whereby the proximal end of the prosthesis is releasably fixed to the apex delivery device at the stent.

17. A delivery device, comprising,

a) a gear rack;

b) a handle extending about the gear rack and defining teeth at an end of the handle, the handle being rotatable about the gear rack;

c) a pinion gear rotatable about an axis that intersects with the axis of rotation of the handle and engages the gear rack;

d) a linking gear that selectively rotates with rotation of the pinion gear;

e) an actuator that selectively engages the pinion gear with the linking gear; and

f) a delivery catheter fixed to the handle, whereby rotation of the handle selectively moves the delivery catheter relative to the gear rack upon engagement of the pinion gear with the linking gear by the actuator.

18. A method for delivering a vascular prosthesis to a treatment site of a subject, comprising the steps of:

a) advancing the vascular prosthesis, while the vascular prosthesis is mounted at a proximal end of the prosthesis to an apex delivery device that is fixed to a distal end of a guidewire catheter, to a position distal to a vascular treatment site of the subject;

b) rotating a proximal handle in a first direction about a handle body, having a distal end, of a delivery device through which the guidewire catheter extends, the guidewire catheter disposed within a push rod that also extends through the handle body, wherein the guidewire catheter is fixed to the push rod, whereby rotation of the proximal handle causes longitudinal movement of the guidewire catheter and the push rod along the handle body to thereby at least partially advance the prosthesis to the treatment site, the prosthesis being advanced from within an outer catheter extending from a distal end of the handle body and about the prosthesis;

c) shifting the position of a first locking component securing the proximal handle to the push rod from a first position to a second position, whereby the first locking component disengages the proximal handle from the push rod and a second locking component engages the push rod with the handle body;

d) rotating the proximal handle in a second direction, whereby a delivery catheter having a distal end, the delivery catheter extending about the push rod, is withdrawn along the push rod, and a delivery sheath extending from the distal end of the delivery catheter is at least partially retracted from about the prosthesis;

e) releasing the proximal end of the prosthesis from the apex delivery device;

f) shifting the second locking component to disengage the push rod from the handle body; and

g) withdrawing the push rod and the guidewire catheter from within the prosthesis, thereby delivering the vascular prosthesis to the treatment site.

19. The method of claim 18, further including the step of disengaging the proximal handle from the handle body, whereby the proximal handle is slidable along the handle body independently of rotation of the proximal handle.

20. The method of claim 19, wherein the proximal handle is disengaged from the handle body while advancing the prosthesis to the treatment site.

21. The method of claim 20, wherein the proximal handle is disengaged from the handle body while retracting the delivery sheath from about the prosthesis.

22. The method of claim 18, wherein the apex delivery device is an apex clasp assembly, whereby apices of a stent of the prosthesis are held by the apex clasp assembly until released.

23. The method of claim 22, wherein the prosthesis is released from the apex clasp assembly by retracting an apex release catheter extending about the guidewire catheter, the apex release catheter being fixed to a proximal capture component of the apex clasp assembly, whereby the proximal capture component of the apex clasp assembly is separated from a distal capture component of the apex clasp assembly, thereby releasing the apices of the stent of the prosthesis from between the proximal and distal capture components.

24. The method of claim 23, wherein rotation of the proximal handle is disengaged from movement of the proximal handle along the handle body by activating an actuator at the proximal handle.

25. The method of claim 24, wherein shifting the position of the first locking component to disengage the proximal handle from the push rod is obtained by rotating a shifting knob having teeth extending about the handle body from a first position to a second position.

26. The method of claim 25, wherein rotating the shifting knob from the first position to the second position simultaneously causes the second locking component to engage the push rod with the handle body.

27. The method of claim 26, wherein the shifting knob is proximate to or at the distal end of the handle body.

28. The method of claim 27, wherein the shifting knob is linked to the proximal handle by a drive shaft having a proximal end and a distal end, wherein the distal end defines teeth that engage, directly or indirectly, teeth of the shifting knob that defines a row of teeth at the proximal end along a major longitudinal axis of the drive shaft.

29. The method of claim 28, wherein the drive shaft engages a drive gear at the proximal end of the drive shaft, whereby the shifting knob is engaged with the drive gear at all positions of the shifting knob.

30. The method of claim 29, wherein the drive gear is engaged with the drive shaft at all positions of the proximal handle along the handle body.